CA2531853A1 - Formulation pharmaceutique comprenant du sodium de levothyroxine - Google Patents

Formulation pharmaceutique comprenant du sodium de levothyroxine Download PDF

Info

Publication number: CA2531853A1
Authority: CA; Canada
Prior art keywords: pharmaceutical formulation; formulation; levothyroxine sodium; microcrystalline cellulose; amount
Prior art date: 2003-07-10
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Granted

Application number

CA002531853A

Other languages

English (en)

Other versions

CA2531853C (fr

Inventor

Malgorzata Konieczna

Heiner Krohn

Wanda Roman

Hendrik Schlehahn

Malgorzata Anna Strozyk

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Aspen Global Inc

Original Assignee

Individual

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2003-07-10

Filing date

2004-07-08

Publication date

2005-01-20

2004-07-08 Application filed by Individual filed Critical Individual

2005-01-20 Publication of CA2531853A1 publication Critical patent/CA2531853A1/fr

2010-09-14 Application granted granted Critical

2010-09-14 Publication of CA2531853C publication Critical patent/CA2531853C/fr

2024-07-08 Anticipated expiration legal-status Critical

Status Expired - Lifetime legal-status Critical Current

Links

239000008194 pharmaceutical composition Substances 0.000 title claims abstract 20
229960003918 levothyroxine sodium Drugs 0.000 title claims abstract 6
XUIIKFGFIJCVMT-LBPRGKRZSA-N L-thyroxine Chemical compound IC1=CC(C[C@H]([NH3+])C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 XUIIKFGFIJCVMT-LBPRGKRZSA-N 0.000 title abstract 2
238000009472 formulation Methods 0.000 claims abstract 6
239000000203 mixture Substances 0.000 claims abstract 6
229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract 5
235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract 5
239000008108 microcrystalline cellulose Substances 0.000 claims abstract 5
229940016286 microcrystalline cellulose Drugs 0.000 claims abstract 5
229920000881 Modified starch Polymers 0.000 claims abstract 4
239000002245 particle Substances 0.000 claims abstract 3
238000000034 method Methods 0.000 claims abstract 2
JMHCCAYJTTWMCX-QWPJCUCISA-M sodium;(2s)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate;pentahydrate Chemical compound O.O.O.O.O.[Na+].IC1=CC(C[C@H](N)C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 JMHCCAYJTTWMCX-QWPJCUCISA-M 0.000 claims 4
AUYYCJSJGJYCDS-LBPRGKRZSA-N Thyrolar Chemical class IC1=CC(C[C@H](N)C(O)=O)=CC(I)=C1OC1=CC=C(O)C(I)=C1 AUYYCJSJGJYCDS-LBPRGKRZSA-N 0.000 claims 3
229940036555 thyroid hormone Drugs 0.000 claims 3
239000005495 thyroid hormone Substances 0.000 claims 3
241000124008 Mammalia Species 0.000 claims 2
VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 2
239000000314 lubricant Substances 0.000 claims 2
HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
238000004519 manufacturing process Methods 0.000 claims 2
238000007906 compression Methods 0.000 claims 1
230000006835 compression Effects 0.000 claims 1
230000007423 decrease Effects 0.000 claims 1
239000003814 drug Substances 0.000 claims 1
235000019359 magnesium stearate Nutrition 0.000 claims 1
238000013160 medical therapy Methods 0.000 claims 1
150000004686 pentahydrates Chemical group 0.000 claims 1
239000000377 silicon dioxide Substances 0.000 claims 1
239000000454 talc Substances 0.000 claims 1
229910052623 talc Inorganic materials 0.000 claims 1
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones

Landscapes

Health & Medical Sciences (AREA)
Public Health (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
Veterinary Medicine (AREA)
Chemical & Material Sciences (AREA)
General Health & Medical Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Medicinal Chemistry (AREA)
Epidemiology (AREA)
Organic Chemistry (AREA)
Bioinformatics & Cheminformatics (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Engineering & Computer Science (AREA)
Endocrinology (AREA)
Diabetes (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

CA2531853A 2003-07-10 2004-07-08 Formulation pharmaceutique comprenant du sodium de levothyroxine Expired - Lifetime CA2531853C (fr)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
GBGB0316206.2A GB0316206D0 (en)	2003-07-10	2003-07-10	Pharmaceutical formulation
GB0316206.2		2003-07-10
PCT/EP2004/007667 WO2005004849A2 (fr)	2003-07-10	2004-07-08	Formulation pharmaceutique

Publications (2)

Publication Number	Publication Date
CA2531853A1 true CA2531853A1 (fr)	2005-01-20
CA2531853C CA2531853C (fr)	2010-09-14

Family

ID=27741962

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
CA2531853A Expired - Lifetime CA2531853C (fr)	2003-07-10	2004-07-08	Formulation pharmaceutique comprenant du sodium de levothyroxine

Country Status (28)

Country	Link
US (1)	US7955621B2 (fr)
EP (1)	EP1643976B1 (fr)
JP (2)	JP4880457B2 (fr)
KR (1)	KR101136655B1 (fr)
CN (1)	CN100430051C (fr)
AR (1)	AR045719A1 (fr)
AT (1)	ATE415949T1 (fr)
AU (1)	AU2004255466B2 (fr)
BR (1)	BRPI0412391B8 (fr)
CA (1)	CA2531853C (fr)
CO (1)	CO5700710A2 (fr)
DE (1)	DE602004018142D1 (fr)
DK (1)	DK1643976T3 (fr)
ES (1)	ES2319193T3 (fr)
GB (1)	GB0316206D0 (fr)
IL (1)	IL172619A (fr)
IS (1)	IS2616B (fr)
MA (1)	MA27898A1 (fr)
MX (1)	MXPA06000353A (fr)
MY (1)	MY140127A (fr)
NO (1)	NO338465B1 (fr)
NZ (1)	NZ544174A (fr)
PL (1)	PL1643976T3 (fr)
PT (1)	PT1643976E (fr)
RU (1)	RU2349345C2 (fr)
TW (1)	TWI329026B (fr)
WO (1)	WO2005004849A2 (fr)
ZA (1)	ZA200510224B (fr)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
ITMI20022394A1 (it)	2002-11-13	2004-05-14	Bracco Spa	Uso di triiodotironina 3-solfato come farmaco ad attivita' tireomimetica e relative formulazioni farmaceutiche.
ITMI20110713A1 (it)	2011-04-29	2012-10-30	Bracco Imaging Spa	Processo per la preparazione di un derivato solfatato di3,5-diiodo-o-[3-iodofenil]-l-tirosina
US8318712B2 (en)	2006-01-06	2012-11-27	Intervet International B.V.	Concentrated liquid thyroid hormone composition
IT1395454B1 (it) *	2009-03-24	2012-09-21	Altergon Sa	Composizioni e forme farmaceutiche per somministrazione orale di ormoni tiroidei in grado di contrastare l'azione di agenti sequestranti nel tratto gastrointestinale
ITMI20112066A1 (it) *	2011-11-14	2013-05-15	Altergon Sa	Preparazione farmaceutica orale monodose di ormoni tiroidei t3 e t4
EP2941272A1 (fr) *	2012-12-21	2015-11-11	Mylan Inc.	Formulation de lévothyroxine avec de la gomme arabique
US9271951B2 (en)	2012-12-21	2016-03-01	Mylan Inc.	Levothyroxine formulation with acacia
WO2014098886A1 (fr) *	2012-12-21	2014-06-26	Mylan Inc.	Formulation de lévothyroxine avec de la carraghénine
EP2932963A1 (fr)	2014-04-16	2015-10-21	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.	Stables firmes galéniques contenant du Lévothyroxine de Sodium
JP6168673B2 (ja)	2015-10-07	2017-07-26	協和発酵キリン株式会社	アリールアルキルアミン化合物含有医薬組成物
WO2017061621A1 (fr)	2015-10-07	2017-04-13	協和発酵キリン株式会社	Composition pharmaceutique contenant un composé d'arylalkylamine
US20200046664A1 (en)	2016-10-10	2020-02-13	Ftf Pharma Private Limited	Method for preparation of liquid oral composition of l-thyroxin
GEP20217241B (en) *	2017-02-03	2021-04-12	Berlin Chemie Ag	Oral thyroid therapeutic agent
IT201800003615A1 (it) *	2018-03-15	2019-09-15	Altergon Sa	Formulazioni altamente stabili di ormone tiroideo in capsule molli
CN118894787A (zh) *	2019-05-05	2024-11-05	上海葆隆生物科技有限公司	一种左甲状腺素钠杂质及其制备
KR20220085086A (ko)	2020-12-14	2022-06-22	메디케어제약 주식회사	갑상선 기능 저하증을 동반한 대사 증후군을 치료하는 약제학적 복합제제
WO2025181833A1 (fr) *	2024-03-01	2025-09-04	Srushti Pharmaceuticals Pvt Ltd	Composition à base de pastilles de sodium de lévothyroxine et procédé de préparation

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US5225204A (en) *	1991-11-05	1993-07-06	Chen Jivn Ren	Stable dosage of levothyroxine sodium and process of production
EP0661934A4 (fr) *	1992-09-22	1996-07-24	Fmc Corp	Produit et procede de production de cellulose microcristalline.
GB9401879D0 (en) *	1994-02-01	1994-03-30	Boots Co Plc	Therapeutic agents
DE19541128C2 (de) *	1995-10-27	1997-11-27	Henning Berlin Gmbh & Co	Stabilisierte schilddrüsenhormonhaltige Arzneimittel
AU712217B2 (en) *	1995-11-14	1999-11-04	Abbott Gmbh & Co. Kg	Stabilized thyroid hormone preparations and methods of making same
JPH11286456A (ja) *	1998-03-31	1999-10-19	Lion Corp	複合粉体組成物及び錠剤
DE19821625C1 (de) *	1998-05-15	2000-01-05	Merck Patent Gmbh	Pharmazeutische Zubereitung
US6190696B1 (en) *	1998-06-08	2001-02-20	Pieter J. Groenewoud	Stabilized thyroxine medications
JP2001064177A (ja) *	1999-08-16	2001-03-13	Schering Ag	ベンズアミド誘導体を有効成分とする製剤
JP3435664B2 (ja) *	1999-12-08	2003-08-11	ヤンセンファーマ株式会社	口腔内速崩壊型錠剤及びその製造方法
US6399101B1 (en)	2000-03-30	2002-06-04	Mova Pharmaceutical Corp.	Stable thyroid hormone preparations and method of making same
US6555581B1 (en) *	2001-02-15	2003-04-29	Jones Pharma, Inc.	Levothyroxine compositions and methods
US20030032675A1 (en) *	2001-02-15	2003-02-13	Franz G. Andrew	Manufacture of thyroid hormone tablets having consistent active moiety amounts

2003
- 2003-07-10 GB GBGB0316206.2A patent/GB0316206D0/en not_active Ceased
2004
- 2004-07-08 JP JP2006518170A patent/JP4880457B2/ja not_active Expired - Lifetime
- 2004-07-08 AT AT04740922T patent/ATE415949T1/de active
- 2004-07-08 KR KR1020067000484A patent/KR101136655B1/ko not_active Expired - Lifetime
- 2004-07-08 MX MXPA06000353A patent/MXPA06000353A/es active IP Right Grant
- 2004-07-08 RU RU2006104009/15A patent/RU2349345C2/ru active
- 2004-07-08 CA CA2531853A patent/CA2531853C/fr not_active Expired - Lifetime
- 2004-07-08 ES ES04740922T patent/ES2319193T3/es not_active Expired - Lifetime
- 2004-07-08 AR ARP040102405A patent/AR045719A1/es not_active Application Discontinuation
- 2004-07-08 MY MYPI20042725A patent/MY140127A/en unknown
- 2004-07-08 PL PL04740922T patent/PL1643976T3/pl unknown
- 2004-07-08 EP EP04740922A patent/EP1643976B1/fr not_active Expired - Lifetime
- 2004-07-08 US US10/564,148 patent/US7955621B2/en not_active Expired - Lifetime
- 2004-07-08 TW TW093120412A patent/TWI329026B/zh not_active IP Right Cessation
- 2004-07-08 DK DK04740922T patent/DK1643976T3/da active
- 2004-07-08 WO PCT/EP2004/007667 patent/WO2005004849A2/fr not_active Ceased
- 2004-07-08 BR BRPI0412391A patent/BRPI0412391B8/pt not_active IP Right Cessation
- 2004-07-08 DE DE602004018142T patent/DE602004018142D1/de not_active Expired - Lifetime
- 2004-07-08 CN CNB2004800197743A patent/CN100430051C/zh not_active Expired - Lifetime
- 2004-07-08 NZ NZ544174A patent/NZ544174A/en not_active IP Right Cessation
- 2004-07-08 AU AU2004255466A patent/AU2004255466B2/en not_active Expired
- 2004-07-08 PT PT04740922T patent/PT1643976E/pt unknown
2005
- 2005-12-15 ZA ZA200510224A patent/ZA200510224B/en unknown
- 2005-12-15 IL IL172619A patent/IL172619A/en active IP Right Grant
- 2005-12-30 CO CO05131486A patent/CO5700710A2/es not_active Application Discontinuation
2006
- 2006-01-06 MA MA28702A patent/MA27898A1/fr unknown
- 2006-01-13 NO NO20060208A patent/NO338465B1/no unknown
- 2006-02-07 IS IS8287A patent/IS2616B/is unknown
2011
- 2011-07-21 JP JP2011160067A patent/JP2011213736A/ja active Pending

Also Published As

Publication number	Publication date
JP2009513530A (ja)	2009-04-02
JP4880457B2 (ja)	2012-02-22
IL172619A0 (en)	2006-04-10
HK1089094A1 (en)	2006-11-24
CA2531853C (fr)	2010-09-14
DK1643976T3 (da)	2009-04-06
IS2616B (is)	2010-04-15
MXPA06000353A (es)	2006-03-28
WO2005004849A2 (fr)	2005-01-20
MA27898A1 (fr)	2006-05-02
KR101136655B1 (ko)	2012-04-18
ES2319193T3 (es)	2009-05-05
GB0316206D0 (en)	2003-08-13
ZA200510224B (en)	2007-09-26
NO338465B1 (no)	2016-08-22
JP2011213736A (ja)	2011-10-27
TW200518785A (en)	2005-06-16
RU2349345C2 (ru)	2009-03-20
NZ544174A (en)	2008-07-31
WO2005004849A3 (fr)	2005-05-06
PL1643976T3 (pl)	2009-05-29
EP1643976B1 (fr)	2008-12-03
IL172619A (en)	2010-12-30
AR045719A1 (es)	2005-11-09
NO20060208L (no)	2006-01-13
CN100430051C (zh)	2008-11-05
BRPI0412391B8 (pt)	2021-05-25
US7955621B2 (en)	2011-06-07
CN1819820A (zh)	2006-08-16
ATE415949T1 (de)	2008-12-15
PT1643976E (pt)	2009-03-03
KR20060065628A (ko)	2006-06-14
EP1643976A2 (fr)	2006-04-12
US20070110803A1 (en)	2007-05-17
BRPI0412391B1 (pt)	2017-10-31
AU2004255466A1 (en)	2005-01-20
AU2004255466B2 (en)	2007-07-26
MY140127A (en)	2009-11-30
TWI329026B (en)	2010-08-21
RU2006104009A (ru)	2006-06-27
DE602004018142D1 (de)	2009-01-15
IS8287A (is)	2006-02-07
BRPI0412391A (pt)	2006-09-19
CO5700710A2 (es)	2006-11-30

Legal Events

Date	Code	Title	Description
2009-03-19	EEER	Examination request

Publication	Publication Date	Title
JP3037757B2 (ja)	2000-05-08	パロキセチン錠およびその製法
KR100202154B1 (ko)	1999-06-15	파라세타몰 및 돔페리돈을 함유한 필름 피복 정제
US4839176A (en)	1989-06-13	Therapeutic agents
IS1694B (is)	1998-04-20	Lyfjablanda til að gefa dýrum um munn sem inniheldur prótonupumpublokkara
NZ336789A (en)	2000-11-24	Use of methacrylic acid copolymer type C in the manufacture of tablets
RU2006104009A (ru)	2006-06-27	Фармацевтическая препаративная форма
JP6009967B2 (ja)	2016-10-19	固形製剤
BR9916361A (pt)	2002-11-05	Forma de dosagem de tabletes de liberação controlada, formulação de tablete de liberação controlada, composição granular para prensagem em uma forma de dosagem de tablete de liberação controlada, e, métodos para preparar uma composição granular, para preparar uma forma de dosagem de tabletes de liberação controlada de divalproex sódio e para tratar epilepsia
WO2013122135A1 (fr)	2013-08-22	Composition pharmaceutique orale
JP2022105704A (ja)	2022-07-14	医薬組成物
ATE195073T1 (de)	2000-08-15	Feste pharmazeutische zubereitung mit (s)-2-(4- isobutylphenyl)propionsäure als wirkstoff und mikrokristalliner cellulose und kolloidalem silica als hilfstoff
CA1135189A (fr)	1982-11-09	Comprime d'analgesique
CA2469019A1 (fr)	2003-06-12	Composition pharmaceutique comprenant un recepteur 5ht1
JP2009513530A5 (fr)	2011-01-27
WO2014145285A1 (fr)	2014-09-18	Procédé de fabrication de formes pharmaceutiques effervescentes
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CN101912373B (zh)	2012-01-04	稳定的头孢克洛分散片及其制备方法
RU2007139826A (ru)	2009-05-10	Новые фармацевтические композиции, полезные в лечении болезни паркинсона
JP5490691B2 (ja)	2014-05-14	炭酸カルシウム含有速崩壊性製剤
JP2005154281A (ja)	2005-06-16	関節障害予防及び治療用医薬組成物
JP4824224B2 (ja)	2011-11-30	糖衣製剤
CN103463014B (zh)	2015-08-05	一种复方α-酮酸片及其制备工艺
CN110538161A (zh)	2019-12-06	一种使用于动物产房的聚维酮碘泡腾片及其制备方法
CN101658502A (zh)	2010-03-03	一种甲硝唑缓释片及其制备方法
US4380540A (en)	1983-04-19	Tablets